Expanding the UTHealth Medical Legal Partnership to Improve Mental Health for Low-Income Individuals
2020年11月4日 更新者：Winston Liaw、The University of Texas Health Science Center, Houston
The aim of this study is to test whether participation of low-income patients with health-harming legal needs (HHLNs) in a medical legal partnership (MLP) results in improved mental health, improved quality of life, reduced utilization, and increased resolution of HHLNs.
研究概览
研究类型
介入性
注册 (实际的)
160
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Texas
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Houston、Texas、美国、77093
- Jensen Clinic
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- low-income individuals (Low-income is defined as earning less than 200% of the Federal Poverty Level)
- individuals with HHLNs
- English or Spanish speaking
Exclusion Criteria:
- self-identified as being at significant and immediate risk due to HHLNs (e.g., a situation that involves imminent risk to the patient such as domestic violence)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Medical Legal Partnership
With the medical legal partnership, lawyers are embedded in clinics, and lawyers consult with patients who are identified as having health-harming legal needs (HHLNs).
This arm will also receive usual care, which includes consultation with a social worker and a community health worker.
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With the medical legal partnership, lawyers are embedded in clinics, and lawyers consult with patients who are identified as having health-harming legal needs (HHLNs).
This arm will also receive usual care, which includes consultation with a social worker and a community health worker.
Usual care includes consultation with a social worker and a community health worker.
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有源比较器：Usual Care
Usual care includes consultation with a social worker and a community health worker.
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Usual care includes consultation with a social worker and a community health worker.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Stress as assessed by the Perceived Stress Scale
大体时间：baseline
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The perceived stress scale consists of 10 items, with each item ranging from 0-4, for a total score range of 0-40.
A higher score indicates a worse outcome.
|
baseline
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Stress as assessed by the Perceived Stress Scale
大体时间：3 months
|
The perceived stress scale consists of 10 items, with each item ranging from 0-4, for a total score range of 0-40.
A higher score indicates a worse outcome.
|
3 months
|
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Stress as assessed by the Perceived Stress Scale
大体时间：6 months
|
The perceived stress scale consists of 10 items, with each item ranging from 0-4, for a total score range of 0-40.
A higher score indicates a worse outcome.
|
6 months
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Stress as assessed by the Perceived Stress Scale
大体时间：12 months
|
The perceived stress scale consists of 10 items, with each item ranging from 0-4, for a total score range of 0-40.
A higher score indicates a worse outcome.
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
大体时间：baseline
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The Generalized Anxiety Disorder scale consists of 7 items, with each item ranging from 0-3, for a total score range of 0-21.
A higher score indicates a worse outcome.
|
baseline
|
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Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
大体时间：3 months
|
The Generalized Anxiety Disorder scale consists of 7 items, with each item ranging from 0-3, for a total score range of 0-21.
A higher score indicates a worse outcome.
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3 months
|
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Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
大体时间：6 months
|
The Generalized Anxiety Disorder scale consists of 7 items, with each item ranging from 0-3, for a total score range of 0-21.
A higher score indicates a worse outcome.
|
6 months
|
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Anxiety as assessed by the Generalized Anxiety Disorder 7-item scale
大体时间：12 months
|
The Generalized Anxiety Disorder scale consists of 7 items, with each item ranging from 0-3, for a total score range of 0-21.
A higher score indicates a worse outcome.
|
12 months
|
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Depression as assessed by the Center for Epidemiologic Studies Depression Scale
大体时间：baseline
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The Center for Epidemiologic Studies Depression Scale consists of 20 items, with each item ranging from 0-3, for a total score range of 0-60.
A higher score indicates a worse outcome.
|
baseline
|
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Depression as assessed by the Center for Epidemiologic Studies Depression Scale
大体时间：3 months
|
The Center for Epidemiologic Studies Depression Scale consists of 20 items, with each item ranging from 0-3, for a total score range of 0-60.
A higher score indicates a worse outcome.
|
3 months
|
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Depression as assessed by the Center for Epidemiologic Studies Depression Scale
大体时间：6 months
|
The Center for Epidemiologic Studies Depression Scale consists of 20 items, with each item ranging from 0-3, for a total score range of 0-60.
A higher score indicates a worse outcome.
|
6 months
|
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale
大体时间：12 months
|
The Center for Epidemiologic Studies Depression Scale consists of 20 items, with each item ranging from 0-3, for a total score range of 0-60.
A higher score indicates a worse outcome.
|
12 months
|
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Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
大体时间：baseline
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The Patient-Reported Outcomes Measurement Information System (PROMIS) consists of 29 items, with 28 of the items ranging from 1-5 and 1 item ranging from 0-10, for a total score range of 28-150.
A higher score indicates a worse outcome.
|
baseline
|
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Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
大体时间：3 months
|
The Patient-Reported Outcomes Measurement Information System (PROMIS) consists of 29 items, with 28 of the items ranging from 1-5 and 1 item ranging from 0-10, for a total score range of 28-150.
A higher score indicates a worse outcome.
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3 months
|
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Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
大体时间：6 months
|
The Patient-Reported Outcomes Measurement Information System (PROMIS) consists of 29 items, with 28 of the items ranging from 1-5 and 1 item ranging from 0-10, for a total score range of 28-150.
A higher score indicates a worse outcome.
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6 months
|
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Quality of life as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
大体时间：12 months
|
The Patient-Reported Outcomes Measurement Information System (PROMIS) consists of 29 items, with 28 of the items ranging from 1-5 and 1 item ranging from 0-10, for a total score range of 28-150.
A higher score indicates a worse outcome.
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12 months
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Number of Urgent Care Visits
大体时间：baseline
|
baseline
|
|
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Number of Urgent Care Visits
大体时间：3 months
|
3 months
|
|
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Number of Urgent Care Visits
大体时间：6 months
|
6 months
|
|
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Number of Urgent Care Visits
大体时间：12 months
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12 months
|
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Number of Emergency Department Visits
大体时间：baseline
|
baseline
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Number of Emergency Department Visits
大体时间：3 months
|
3 months
|
|
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Number of Emergency Department Visits
大体时间：6 months
|
6 months
|
|
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Number of Emergency Department Visits
大体时间：12 months
|
12 months
|
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Number of Hospital Visits
大体时间：baseline
|
baseline
|
|
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Number of Hospital Visits
大体时间：3 months
|
3 months
|
|
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Number of Hospital Visits
大体时间：6 months
|
6 months
|
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Number of Hospital Visits
大体时间：12 months
|
12 months
|
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Percentage of baseline health-harming legal needs that were resolved
大体时间：baseline
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baseline
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Percentage of baseline health-harming legal needs that were resolved
大体时间：3 months
|
3 months
|
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Percentage of baseline health-harming legal needs that were resolved
大体时间：6 months
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6 months
|
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Percentage of baseline health-harming legal needs that were resolved
大体时间：12 months
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12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Winston Liaw, MD, MPH、The University of Texas Health Science Center, Houston
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年2月14日
初级完成 (实际的)
2020年9月11日
研究完成 (实际的)
2020年9月11日
研究注册日期
首次提交
2019年1月11日
首先提交符合 QC 标准的
2019年1月11日
首次发布 (实际的)
2019年1月15日
研究记录更新
最后更新发布 (实际的)
2020年11月6日
上次提交的符合 QC 标准的更新
2020年11月4日
最后验证
2020年11月1日
更多信息
与本研究相关的术语
其他研究编号
- HSC-MS-18-1037
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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